December 2021

New Products

• Casirivimab/imdevimab (Ronapreve) are two recombinant human monoclonal antibodies which are unmodified in the Fc regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor binding domain (RBD) of SARS-CoV-2 with dissociation constants K_D = 45.8 picoM and 46.7 picoM, respectively. Casirivimab, imdevimab and casirivimab and imdevimab together blocked RBD binding to the human ACE2 receptor with IC₅₀ values of 56.4 picoM, 165 picoM and 81.8 picoM, respectively. Ronapreve has provisional approval for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19; and for prevention of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to SARS-CoV-2 AND who either: have a medical condition making them unlikely to respond to or be protected by vaccination, or are not vaccinated against COVID-19. Ronapreve solution for infusion contains casirivimab 120 mg/mL and imdevimab 120 mg/mL in separate vials and is available in pack sizes of 1 + 1 single-use or 1 + 1 multidose vials.
   
• Labetalol hydrochloride (Labetalol SXP) lowers blood pressure primarily by blocking peripheral arteriolar alpha-adrenoceptors thus reducing peripheral resistance and, by concurrent beta-blockade, protects the heart from reflex sympathetic drive that would otherwise occur. Labetalol SXP is indicated for the emergency treatment of severe hypertension when prompt and urgent reduction of blood pressure is essential. It is contraindicated in patients with a history of asthma or a history of obstructive pulmonary disease; bradycardia (< 45-50 bpm); sick sinus syndrome (including sino-atrial block); second or third degree heart block; cardiogenic shock; symptomatic heart failure; severe peripheral circulatory disturbances; metabolic acidosis; untreated phaeochromocytoma; Prinzmetal's angina; where peripheral vasoconstriction suggests low cardiac output, to control hypertensive episodes following acute myocardial infarction; hypotension; right ventricular failure secondary to pulmonary hypertension; and significant right ventricular hypertrophy. Labetalol SXP solution for injection contains labetalol hydrochloride 50 mg/10 mL and is available in a pack size of 10.
   
• Lanadelumab (Takhzyro) is a fully human, monoclonal antibody (IgG1/_K-light chain) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lanadelumab inhibits active plasma kallikrein proteolytic activity without binding prekallikrein, the inactive precursor found in the circulation. Increased plasma kallikrein activity leads to angioedema attacks in patients with hereditary angioedema (HAE). Lanadelumab provides sustained control of plasma kallikrein activity and thereby limits bradykinin generation in patients with HAE. Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (C1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older. Takhzyro solution for injection contains lanadelumab 300 mg/2 mL and is available in pack sizes of 1 prefilled syringe or 1 single-dose vial.

New Indications

• Anidulafungin (Eraxis) is now indicated for invasive candidiasis, including candidaemia in adult and paediatric patients one month and older.
   
• Influenza virus vaccine, surface antigen, quadrivalent (inactivated) (Influvac Tetra) is now indicated in adults and children from 6 months of age and older.

New Contraindications

• Meloxicam (Mobic) is now contraindicated in pregnancy.

This list is a summary of only some of the changes that have occurred over the last month.
Before prescribing, always refer to the full product information.